Functional Electrical Stimulation (FES) Assisted Walking: Enhancement of Walking Function After Stroke

NCT00552916 | Unknown Phase 4

• 1 other identifier: SRA 5973
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if a form of exercise,known as electrical stimulation can improve walking function and other important health outcomes. The hypothesis is that electrical stimulation can enhance the ability to walk for stroke survivors who are unable to walk on their on their own.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• The ability of FES-Assisted Walking to stimulate or improve walking ability using a dichotomous outcome i.e. yes/no stimulation or improvement of walking ability on a two-minute walk test.

  Test performed weekly during 8-week period as well as at 2 month and 6 month time point.

Secondary Outcomes (3)

• Assessment of balance by completing four tests i.e. move from a seated to a standing position, completion of activities of daily living tasks such as moving from a bed to a wheelchair, standing with eyes opened and closed.

  Baseline, 2 month and 6 month period.

• Bone density at hip, spine, proximal tibia and distal femur using dual-energy xray absorptiometry

  Baseline, 2-month and 6-month

• Assess functional abilities by performing various tasks using our leg and foot as well as your ability to perform functional tasks such as eating, grooming and bathing.

  Baseline, 2-month and 6-month time points.

Study Arms (2)

1

OTHER

Participants will be randomized to either an intervention arm where they will receive 'true' FES and the other control arm where they will receive 'false' FES. The sham group will receive 'false' FES.

Device: Compex Motion Stimulator

2

OTHER

The intervention group will receive 'true' FES

Device: Compex Motion Stimulator

Interventions

Compex Motion Stimulator DEVICE

'True' Functional Electrical Stimulation Assisted Walking

2

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Hemiplegic stroke at least 12 months prior to joining the study.
• Age 65 years or greater.
• Ability to follow instructions and to devote his/her attention to therapy.
• Ability to understand instructions in English and able to provide informed consent.

You may not qualify if:

• Severe difficulties with attention such that informed consent cannot be obtained, or that safety or communication would be comprised.
• Ability to walk more that 10 meters during a two minute walk with an average speed greater than 0.8 m/s.
• The presence of skin rashes, allergies or bruises where electrodes would be placed.
• History of seizures, edema in paralyzed limbs or co-morbidities such as Parkinson's Disease, cancer or osteoarthritis to be confirmed by attending physiatrist.

Sponsors & Collaborators

• Toronto Rehabilitation Institute: lead
• Heart and Stroke Foundation of Ontario: collaborator

Study Sites (1)

Toronto Rehabilitation Institute: Lyndhurst Centre

Toronto, Ontario, M4G 3V9, Canada

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Milos R Popovic, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naaz Kapadia, MSc

CONTACT

416-597-3422; kapadia.naaz@torontorehab.on.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 2007
• First Posted: November 2, 2007
• Study Start: October 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: August 20, 2008

Record last verified: 2008-08

Locations

CA (1)